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SYSMEX CORPORATION

Japan·JP-MF-000014037

Last updated September 17, 2026

Information

Country: Japan
Address: 4-4-4 Takatsukadai, Nishi-ku, Kobe, Japan
Website: sysmex.co.jp
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(888)879-7644
PRRC Contact: Yasumasa Akai
EUDAMED SRN: JP-MF-000014037
FDA FEI Number: 3010421384
DUNS Number: 690664461

Catalogue (164)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
Lysercell WDF	AW-993-605	EUDAMEDFDA UDI	Class A	Active
Sa-90	BX718746	EUDAMED	Class A	Active
Xf-1600 Tbnk Sw	CB493081	EUDAMED	Class A	Active
Cv-55	CU287365	EUDAMED	Class A	Active
Rr-10(w/O Dcl)	AP594052	EUDAMED	Class A	Active
Xn Cal	BC553492	EUDAMED	IVD General	Active
Ca Clean Ii	974-0581-0	EUDAMED	Class A	Active
UF- Fluorocell CR	BW056982	EUDAMED	Class A	Active
Uc-1000	AT167927	EUDAMED	Class A	Active
St-10	BQ027353	EUDAMED	Class A	Active
Sa-21	BP758948	EUDAMED	Class A	Active
Cv-60	CE944580	EUDAMED	Class A	Active
HISCL Substrate Reagent Set	BE210342	EUDAMED	Class A	Active
Ca-660	CK978289	EUDAMEDFDA UDI	Class A	Active
Sp-50	BX765805	EUDAMED	Class A	Active
Ts-01	AU291973	EUDAMED	Class A	Active
Xn Check Bf	BA448553	EUDAMED	IVD General	Active
Automated Immunoassay System HISCL-5000	AF022051	EUDAMED	Class A	Active
Line Washing Solution Supply Unit LU-10	BR373361	EUDAMED	Class A	Active
Automated Immunoassay System HISCL-800	AE999369	EUDAMED	Class A	Active
Stromatolyser-3wp	854-0012-1	EUDAMEDFDA UDI	Class A	Active
HISCL β-Amyloid 1-40 Assay kit	BV419142	EUDAMED	IVD General	Active
Bt-40	BT080317	EUDAMED	Class A	Active
Cn-6000	CV339763	EUDAMEDFDA UDI	Class A	Active
HISCL Washing Solution	BA362196	EUDAMED	Class A	Active
Cn-6000	CV339763	EUDAMEDFDA UDI	Class A	Active
Lysercell M	CJ-760-691	EUDAMED	Class A	Active
Ps-10	BQ716341	EUDAMEDFDA UDI	Class A	Active
Rd-210	CP437283	EUDAMED	Class A	Active
Suc-400a	064-1481-0	EUDAMED	Class A	Active
Pneumatic Unit PU-13	07316038	EUDAMED	Class A	Active
Uf-Cellpack Cr	CB-505-392	EUDAMEDFDA UDI	Class A	Active
Su-40	904-0721-9	EUDAMED	Class A	Active
Ca Clean Ii	96406136	EUDAMED	Class A	Active
Cellpack	834-0011-10	EUDAMEDFDA UDI	Class A	Active
CyFlow SHEATH	AY104869	EUDAMED	Class A	Active
U-Wam	AM594637	EUDAMED	Class A	Active
Fluorocell M	CA-006-592	EUDAMED	Class A	Active
HISCL Line Washing Solution Concentrated	BH387965	EUDAMED	Class A	Active
SA-52 Sampler Unit	AR763673	EUDAMED	Class A	Active
Sulfolyser	SLS-220A	EUDAMEDFDA UDI	Class A	Active
Cs-5100	BY990757	EUDAMEDFDA UDI	Class A	Active
Lysercell WDF	AZ-124-801	EUDAMED	Class A	Active
Uf-5000	BN344411	EUDAMED	IVD General	Active
Xn-L Check	CC211992	EUDAMED	IVD General	Active
Cellpack Dcl	CT-661-628	EUDAMEDFDA UDI	Class A	Active
pocH-pack 65XL	CQ-711-695	EUDAMED	Class A	Active
e-CHECK(XS)	CL552365	EUDAMED	IVD General	Active
SB Cuvette II	CM500820	EUDAMED	Class A	Active
Uf-Cellpack Sf	CE-604-532	EUDAMEDFDA UDI	Class A	Active

Related Companies

Authorised Representatives

Sysmex Europe SE DE

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Sysmex Corp. US